Registration Dossier
Registration Dossier
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EC number: 270-299-2 | CAS number: 68424-38-4 This substance is identified by SDA Substance Name: C16-C18 alkyl carboxylic acid sodium salt and SDA Reporting Number: 19-006-04.
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Lauric acid
- EC Number:
- 205-582-1
- EC Name:
- Lauric acid
- Cas Number:
- 143-07-7
- IUPAC Name:
- lauric acid
- Reference substance name:
- [TN]Fatty acid C 16-18, sodium salt[/TN][SPEC][/SPEC][AM][/AM]
- IUPAC Name:
- [TN]Fatty acid C 16-18, sodium salt[/TN][SPEC][/SPEC][AM][/AM]
- Details on test material:
- no data
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright-white
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Mean weight at study initiation: 374g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 2.5% Laurinsäure in ethanol
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 2.5% Laurinsäure in ethanol
- No. of animals per dose:
- 20
- Details on study design:
- The implementation of the experiment was carried out by the method of Magnusson and Kligman, the rechallenge was performed with a 2.5% lauric acid in ethanol in an occlusive form with a contact time of 24 hours.
The observation times of the maximisation procedure was 24 and 48 hours after removal of the patch. - Challenge controls:
- no data
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2.5% lauric acid
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no observations
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5% lauric acid. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no observations.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Lauric acid has no allergic reactions in guinea pigs.
- Executive summary:
The Guinea pig maximisation test of Magnusson and Kligman was performed to reveal a possible sensitising potential of lauric acid. Investigations performed were in conformance with the OECD Guideline 406.
Ten female guinea pigs were used as a test substance group and another 10 females were used as a negative control group. The rechallenge was performed with a 2.5% lauric acid in ethanol in an occlusive form with a contact time of 24 hours. The observation times of the maximization procedure was 24 and 48 hours after removal of the patch.
General:
All animals survived till the end of the study. No ill health or toxicity effects were noted.
Skin reactions after rechallenge:
The application sites of all control animals were normal at each time.
There were no dermal reactions seen in any of the test or control animals.
The test substance lauric acid is not sensitising.
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